Tooth LossNCT04838184
Short Implants in Edentulous Mandible
An observational study of Tooth Loss and Edentulous Jaw, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
Main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Edentulous Jaw
- What is being tested?
- Dental Implants (Straumann Roxolid® / SLActive®)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2015to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dental patients of university-based prosthodontic department (primary, secondary, and tertiary care clinic)
Who may be able to join
- General criteria:
- Age: 18 to 70
- Edentulous mandible with reduced bone level in the posterior region (> 5 mm and < 8 mm above nerve conduit)
- Physical and mental condition that allow surgery and a 5-year follow-up period to be carried out without foreseeable problems
- Obtained informed consent from the patient
- Specific criteria:
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- Limited vertical space for implant placement, where conventional implants with lengths of more than 4 mm cannot be used
- Tooth loss or extraction at least 8 weeks before implant surgery
- Healthy implantation site
- Favorable and stable occlusal relationship
- Complete denture in the mandible. If no denture available, an interims prosthesis will be fitted
- Natural full dentition or sufficient complete or partial dentures in the maxilla
Who cannot join
- General criteria:
- Any conditions or circumstances which would interfere with the requirements for oral surgery
- Allergy to any metallic implant component
- Acute, untreated periodontitis
- Previous oro-maxillo-facial radiotherapy
- Any disorders in the planned implant area such as previous tumors or chronic bone disease (e.g., rheumatoid disease)
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- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.)
- Alcohol or drug abuse
- Heavy smoking (>10 cigarettes/day)
- Uncontrolled diabetes
- Severe bruxism or other destructive oral habits
- Pregnant or lactating women
- Specific criteria:
- Need for a major bone regeneration technique
- Infections in adjacent tissue of the planned implantation site.
- Bleeding on probing (BOP) and plaque index (PI) higher 25%
- Insufficient bone volume in the posterior region for placing a Straumann Roxolid® / SLActive® 4mm short implant and in the interforaminal region for placing a Straumann Roxolid® / SLActive® implant with a minimum length of 10 mm determined by radiographic analysis (OPG)
About this study
Official title: Prospective Clinical Study of Straumann Roxolid®/SLactive® Short Implants in Edentulous Mandible
Main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years.
Read the detailed description
It is hypothesized that survival rates after 1, 3, and 5 years of Straumann Roxolid® / SLActive® 4 mm short implants do not differ from values of Straumann SLActive implants with more than 4 mm length in the same clinical situation.
- Conditions
- Tooth Loss, Edentulous Jaw
- Being tested
- Dental Implants (Straumann Roxolid® / SLActive®)
- Medical subject headings
- Tooth Loss, Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implants (Straumann Roxolid® / SLActive®)Device
In this study the 4 mm implants will be inserted in the area surrounding 36/46. The implant diameters will be defined based on the patient's situation.
In the interforaminal region, two implants of conventional length with a minimum of 10 mm will be inserted. The implant diameter and the length will be defined based on the patient's situation.
| Study group | Role | What they receive |
|---|---|---|
| Dental patients | Patients with an edentulous mandible who are demanding and receiving an implant-supported fixed dental prosthesis in the mandible Receives: Device: Dental Implants (Straumann Roxolid® / SLActive®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival of implants and suprastructure. Measure: survival rates
Measured: 5 years
Secondary outcomes (4)
Implant stability
Within-subject comparison of primary (at implant placement) and secondary (at implant exposure) stability of short versus regular length implants.
Measure / device: Resonance Frequency Analysis (RFA)
Measured: 3 months
Success
Success of implants and suprastructure. Measure: success rates
- Biological success:
- No detectable clinical mobility (hand testing)
- No radiolucency surrounding the total surface of the implant
- No persistent pain refractory to medical therapy
- No recurrent peri-implant infection
- Peri-implant infection: peri-implant Probing Depth (PD), Plaque Index (Pl), and Bleeding on Probing (BoP)
- Bone loss: standardized intra-oral radiography with long-cone parallel technique
- Technical success:
- No screw loosening
- No fracture of metal base
- No fracture of veneering material
Measured: 5 years
Oral health-related quality of life
Oral health-related quality of life (OHRQoL). Measure: questionnaire
- 49-item Oral Health Impact Profile (OHIP) with a 5-point ordinal rating scale (possible range of summary scores: 0-196 with higher scores indicating more impairment)
Measured: 5 years
Patient satisfaction
Patient satisfaction. Measure: questionnaire
- Visual analogue scales (VAS) on ease of cleaning, speech, comfort, esthetic, stability, chewing ability, masticatory function, and oral health (possible range of scores: 0-10 for each item with higher scores indicating more satisfaction)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start19 Apr 2015
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Straumann AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838184
- Sponsor's protocol ID
- PV_4805
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Straumann Roxolid®/SLactive® Short Implants in Edentulous Mandible
- ClinicalTrials.gov ID
- NCT04838184
- Acronym / sponsor ID
- PV_4805
- Conditions
- Tooth Loss, Edentulous Jaw
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Straumann AG
- Study start
- 19 Apr 2015 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years.
Detailed description
It is hypothesized that survival rates after 1, 3, and 5 years of Straumann Roxolid® / SLActive® 4 mm short implants do not differ from values of Straumann SLActive implants with more than 4 mm length in the same clinical situation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental patients | – | Device: Dental Implants (Straumann Roxolid® / SLActive®)Patients with an edentulous mandible who are demanding and receiving an implant-supported fixed dental prosthesis in the mandible |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dental patients of university-based prosthodontic department (primary, secondary, and tertiary care clinic)
Key inclusion criteria (12 listed)
- Age: 18 to 70
- Edentulous mandible with reduced bone level in the posterior region (> 5 mm and < 8 mm above nerve conduit)
- Physical and mental condition that allow surgery and a 5-year follow-up period to be carried out without foreseeable problems
- Obtained informed consent from the patient
- Limited vertical space for implant placement, where conventional implants with lengths of more than 4 mm cannot be used
Key exclusion criteria (17 listed)
- Any conditions or circumstances which would interfere with the requirements for oral surgery
- Allergy to any metallic implant component
- Acute, untreated periodontitis
- Previous oro-maxillo-facial radiotherapy
- Any disorders in the planned implant area such as previous tumors or chronic bone disease (e.g., rheumatoid disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental Implants (Straumann Roxolid® / SLActive®)In this study the 4 mm implants will be inserted in the area surrounding 36/46. The implant diameters will be defined based on the patient's situation. In the interforaminal region, two implants of conventional length with a minimum of 10 mm will be inserted. The implant diameter and the length will be defined based on the patient's situation. | Device | Dental patients |
Primary outcome
Survival
Time frame: 5 years
Survival of implants and suprastructure. Measure: survival rates
4 secondary outcomes
Implant stability
Time frame: 3 months
Success
Time frame: 5 years
Oral health-related quality of life
Time frame: 5 years
Patient satisfaction
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss and Edentulous Jaw, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.